【発明の詳細な説明】テンションガイドおよび拡張器発明の背景１、発明の分野本発明は体腔内部への経皮アクセスを可能にするための装置および方法に関する。具体的には、本発明は中空体腔への比較的大きな穿通を可能にするために１以上の拡張部材を導入するための装置の構成および用途に関する。[Detailed description of the invention]Tension guides and dilatorsBackground of the invention1. Field of inventionThe present invention relates to devices and methods for providing percutaneous access to the interior of body cavities.. Specifically, the present invention provides one or moreThe present invention relates to the configuration and use of a device for introducing the above expansion member.
中空身体器官の内部へアクセスするために患者の皮膚を経皮穿通する必要が種々の環境下で発生する。例えば、各種カテーテル、カニユーレ等は体腔を吸引し、体腔へ薬剤を導入し、体腔内で介入処置を施す等のために導入される。様々な処置に適した穿孔を形成するために種々の装置および方法が開発されている。Various instances require percutaneous penetration of a patient's skin to access the interior of hollow body organs.Occurs under the following circumstances. For example, various catheters, cannulas, etc. suction the body cavity,It is used to introduce drugs into body cavities and perform interventional procedures within body cavities. various placesVarious devices and methods have been developed to form perforations suitable for the site.
体腔内部へアクセスするための共通試案はトロカールとカニユーレとの組立体を利用する。トロカールは鋭利先端を有する金属ロッドであり、カニユーレはその軸管内にトロカールを受ける中空管である。カニユーレの前方へ鋭利先端が延びるようにトロカールを適所へ設置して該組立体を体腔へ、典型的には小さい穿刺孔から、導入する。そこで、トロカールを除去し、カニユーレを適所に保留して、その孔から体腔内部へアクセスする。A common method for accessing the inside of a body cavity is the assembly of a trocar and cannula.Make use of it. A trocar is a metal rod with a sharp tip, and a cannula is a metal rod with a sharp tip.It is a hollow tube that receives a trocar within the axial tube. The sharp tip extends toward the front of the cannula.Place the trocar in place and insert the assembly into the body cavity, typically through a small puncture.Introduce it through the hole. The trocar was then removed and the cannula was kept in place., through which the inside of the body cavity is accessed.
かかるトロカールとカニユーレとの組立体は長年使用されており、現在も多くの従来処置に適したものとして使用されている。しかし、カニユーレの周りの穿刺孔から比較的大きなカニユーレまたは他の装置を導入したいときには、大きな制限が伴う。初期穿刺孔は典型的には小さく、大きな装置を導入させるには拡張しなければならない。拡張は該穿刺孔から中空身体器官へ次第に拡大する径を有する１以上の拡張ロッドを、典型的にはカニユーレから導入された可撓性ガイドワイヤ上に、継続的に導入することにより実施されるのが典型的であり、その後にカニユーレは除去される。拡張ロッドは典型例としてその導入を容易にするために先細り遠位端部を有しかつガイドワイヤを受けるために小さい中心孔を有する。かかる従来の拡張ロッドは、皮膚に比較的接近する、かつ／またはその構造によりまたは周囲筋膜との結合により軸運動から拘束される体腔へ進入するときに概ね連続的に使用される。Such trocar and cannula assemblies have been used for many years, and many still exist today.It is used as suitable for conventional treatment. However, puncture around the canyuleWhen it is desired to introduce a relatively large cannula or other device through the hole, significant restrictions may be required.There are limitations. The initial puncture hole is typically small and must be dilated to introduce a larger device.There must be. The expansion has a diameter that gradually expands from the puncture hole into the hollow body organ.one or more dilator rods, typically introduced through a cannula, through a flexible guide wire.This is typically done through initial, continuous implementation, followed byThe cannula is removed. Expansion rods are typically used to facilitate their introduction.has a tapered distal end and a small central bore for receiving the guide wire.. Such conventional dilator rods are relatively close to the skin and/or in its structure.when entering a body cavity that is restrained from axial movement by theUsed almost continuously.
拡張ロッドの使用は軸方向の拘束を受けない身体器官、例えば、胆嚢、膀胱、胃等であって、そこから移動し易くかつ急傾斜の拡張ロッドの進入にさえ抵抗する身体器官では成功していない。この問題は入口点でわずかに座屈したりまたは湾曲する傾向のある可撓性ガイドワイヤで最悪であり、ガイドワイヤの非拘束遠位部は中空身体器官内の位置から引っ張り出される。ガイドワイヤとガイドワイヤにより形成された入口通路の結果的不整合はその構造壁の湾曲と陥入を起こし、更に周囲筋膜から身体器官を引き裂くことにより穿刺アクセスを拡張する問題を悪化させる。The use of expansion rods is recommended for body organs that are not axially constrained, such as the gallbladder, bladder, and stomach.etc., from which it is easy to move and resists even the entry of steeply inclined expansion rods.It has not been successful in body organs. This problem is caused by slight buckling or baying at the entry point.Worst with flexible guidewires that tend to bend and unconstrained distal end of the guidewire.The part is pulled out of its position within the hollow body organ. guidewire and guidewireThe resulting misalignment of the inlet passageway formed by causes curvature and invagination of its structural walls;Further addresses the problem of expanding puncture access by tearing body organs from the surrounding fascia.make worse.
上記問題を少なくとも部分的に克服するために種々の技術および装置か開発された。例えば、非常に緩やかに傾斜した遠位端部に連結された非常に僅かな増分拡大径を有する拡張器は筋膜剥離の発生率を低下させる。しかし、この試案は必ずしも成功せず、かつより長い、より傾斜した拡張器および／またはより多数の拡張器の使用を必要とすることにより拡張器の操作を困難とし、かっ／またその処置を行う時間を必要とする。Various techniques and devices have been developed to at least partially overcome the above problems.Ta. For example, very slight incremental expansion coupled to a very gently sloped distal end.Dilators with larger diameters reduce the incidence of fascial dissection. However, this proposal mustIf unsuccessful, use a longer, more angled dilator and/or a larger number of dilators.Requiring the use of a dilator may make the dilator difficult to operate and/or its treatment.It takes time to set up.
弁体内器官の筋膜剥離を防ぐための他の試案は複数の分離アンカまたはトグルを使用する。このアンカまたはトグルは身体器官と周囲筋膜とを更に強力に結合するために初期穿刺場所周辺に設置される。かかる試案は概ね実用可能であるが、各アンカに独立の穿刺を必要としかつ続く各アンカの適所での縫合を必要とする。更に、かかるアンカは患者の不快感を増すと同時に処置時間を増大させる。Other strategies to prevent fascial avulsion of intravalvular organs include multiple isolation anchors or toggles.use. This anchor or toggle provides a stronger connection between body organs and surrounding fascia.Placed around the initial puncture site to ensure Although such a proposal is generally practical,Requires separate puncture of each anchor and subsequent suturing of each anchor in place. Furthermore, such anchors increase patient discomfort as well as increase procedure time.
上記理由から、中空身体器官および体腔へ経皮穿孔を形成かつ拡大するための方法および装置の改良が望まれる。この装置および方法は付加的時間および関連する介入処置に必要とされる煩雑さを最小限にするものであり、特に周囲筋膜へ身体器官を固定するための第２穿孔を必要としないものである。この方法は２０フレンチ、２４フレンチのオーダの非常に大きい径を含みかつ拡張器ガイド部材の座屈および不整合を解消するより大きい、実質的直径を有する拡張器の導入に適するものである。更に、上記方法および装置は体腔内部へのアクセスのために経皮穿通の形成を必要とする実質的に如何なるタイプの介入処置にも適応するものである。For the above reasons, methods for creating and enlarging percutaneous perforations into hollow body organs and cavities.Improvements in methods and devices are desired. This device and method requires additional time andIt minimizes the complication required for interventional procedures, especially when it comes to surrounding fascia.There is no need for a second perforation for fixing body organs. This method uses 20 frames.wrench, including a very large diameter on the order of 24 French and for dilator guide members.Suitable for introducing dilators with larger, substantial diameters that eliminate buckling and misalignment.It is something to do. Additionally, the methods and devices described above may be used to provide access to the interior of a body cavity.Suitable for virtually any type of interventional procedure requiring the creation of a skin penetrationIt is.
２ 背景技術の説明ＵＳ特許第４．７７２．２６６号はアクセス孔を拡大しかつ鎖孔を更に拡大する鞘を進入させるために身体導入されたガイドワイヤ上を通過できる拡張器／箱組゛立体について記載している。ＵＳ特許第１．２１３．００１号は３ピ一ス構造体を構成する中間管を含むトロカールとカニユーレとの組立体について記載している。ＵＳ特許第３．７４２．９５８号はカニユーレを介してワーキングカテーテルからカニユーレを剥ぎ取ることのできる軸孔を有するカニユーレを開示している。ＵＳ特許第４、８８８．０００号、同第４．８６５．５９３号、同第４．５８１．０２５号、同第３．５４５．４４３号、および同第１．２４８．４９２号の各々は体腔、血管、または中実組織の経皮穿通に適した装置を記載している。これらのＵＳ特許の各々の開示内容は本発明で参考にされている。Ｈｕｉｂｒｅｇｔｓｅ、 ＥｉｎｄｏｓｃｏｐｉｃＢ１１１ａｒｙ ａｎｄ Ｐａｎｃｒｅａｔｉｃ Ｄｒａ、ｉｎａｇｅ、 ３−５頁（１９８８年）は胆管狭窄へエンドプロテーゼ（ｅｎｄｏｐｒｏｓｔｈｅｓｉｓ）を導入するためのフォガーティバルーンカテーテルの使用について記載している。フロリダ州、ゲイアズビルのＮａｔｉｏｎａｌ ５ｔａｎｄａｒｄ Ｐｒｏｄｕｃｔｓは“Ｈａｗｋｉｎｓ ＢｒｅａｓｔＬｏｃａｌｉｚａｔｉｏｎ Ｎｅｅｄｌｅ“の題名の製品説明書に記載されているように胆嚢、その他の中空人体器官へカテーテルを経皮導入する方法について同時係属出願第０７／４０７．８３９号、同第０７１５２９．０７７号、および同第０７１５５１．９７１号に記載しており、その開示内容は本発明で参考にされている。2 Description of background technologyUS Pat. No. 4,772,266 enlarges the access hole and further enlarges the chain hole.Dilator/box assembly that can be passed over a guidewire introduced into the body to advance the sheath゛It describes three-dimensional objects. US Patent No. 1.213.001 has a three-piece structureDescribes the assembly of the trocar and cannula, including the intermediate tube that makes up the body.There is. US Patent No. 3.742.958 discloses that the working catheter isDiscloses a cannula having an axial hole that allows the cannula to be stripped from the tail.There is. US Pat. No. 4,888.000, US Pat. No. 4.865.593, US Pat.581.025, 3.545.443, and 1.248.492Each number describes a device suitable for percutaneous penetration of body cavities, blood vessels, or solid tissue.. The disclosures of each of these US patents are incorporated herein by reference. Huibregtse, Eindoscopic B111ary and Pancreatic Dra, inage, pp. 3-5 (1988) is the end to bile duct stricture.Fogartiva for introducing endoprosthesisDescribes the use of the Loon catheter. N in Gayersville, Floridaational 5 standard Products are “Hawkins BIt is written in the product manual titled “eastLocalization Needle”.Those who percutaneously introduce a catheter into the gallbladder or other hollow human organs as described in the article.Co-pending Application No. 07/407.839 and No. 071529.077 on the LawNo. 071551.971, the disclosure content of which is disclosed in the present invention.It is used as a reference.
発明の概要本発明によれば、中空身体器官および体腔へ経皮穿孔を形成してそれを拡張するための改良された装置および手順が提供される。上記装置は近位端部および遠位端部を有する細長いガイド部材、および上記手順の拡張段階中に緊張（テンション）下で上記ガイド部材を維持するための手段から成る。上記緊張手段は体腔内に上記ガイド部材を定着するためのアンカ一手段であるのが至便である。更に、上記緊張手段は全長にわたりまたは部分的に上記ガイド部材の剛性を制御するための手段であってよい。上記装置は更に上記ガイド部材により画定された通路上で体腔へ導入されるｌまたはそれ以上の細長い拡張部材を含む。上記ガイド部材上の張力は少なくとも２つの観点から有利である。第１に、かかる張力は上記アンカ一手段を上記穿孔近位の体腔の内面に対して外方へ引っ張り、上記拡張部材を導入するときの身体器官壁の変形または周囲筋膜からの剥離の傾向を減少させる。第２に、上記張力は上記拡張部材を導入するときの上記可撓性ガイド部材の座屈または不整合の傾向を最小限にする。Summary of the inventionAccording to the present invention, percutaneous perforations are formed into hollow body organs and cavities to expand the same.Improved apparatus and procedures are provided for. The above device has proximal and distal ends.an elongated guide member having an end and tensioned during the expansion phase of the above procedure;means for maintaining said guide member under said guide member. The above tension means are inside the body cavity.It is convenient that the guide member is provided as an anchor means for fixing the guide member to the guide member. Furthermore,The tensioning means is for controlling the stiffness of the guide member over its entire length or in parts.It may be a means of The device further includes: a passageway defined by the guide member;1 or more elongate expansion members that are introduced into the body cavity at a time. The above guide memberThe above tension is advantageous from at least two points of view. First, the tension ispulling the anchor means outwardly against the inner surface of the body cavity proximal to the perforation, andReduces the tendency of body organ walls to deform or detach from the surrounding fascia when introducingRu. Second, the tension is applied to the flexible guide member when introducing the expansion member.Minimize the tendency for buckling or misalignment.
かかる座屈および不整合は上記拡張部材を所望穿通から偏向させる。Such buckling and misalignment may deflect the expansion member from desired penetration.
上記ガイド部材および上記拡張器の特定構造はアクセスする身体器官の性質に依り可変である。上記ガイド部材および／または拡張器は実質的に剛性または実質的に可撓性であり、体腔への進入路の蛇行性に依存する。概ね直線通路から接近できる比較的アクセスし易い器官に対しては、上記ガイド部材は、通常、硬質であり、一体的鋭利端部により、またはトロカールを使用するカニユーレの導入に似た方法で内部スタイレットによって導入できる。蛇行性接近路を必要とするアクセスしにくい器官に対しては、上記ガイド部材は、通常、可撓性ガイドワイヤの可撓性を育する。いずれの場合にも、上記ガイド部材上のアンカ一手段は、通常、収縮または屈曲自在であり、上記アンカ一手段を収縮させて上記ガイド部材を挿入または除去でき、かつ上記ガイド部材の遠位端部が体腔内部へ達した後にのみ上記アンカ一手段を伸張させる。上記ガイド部材の遠位端部上へ力を加えることにより上記ガイド部材の長手にわたって張力を付与するために内部剛性ワイヤ等の適宜剛性手段が上記ガイド部材へ選択的に導入されてよい。上記拡張器は、通常、上記ガイド部材上へ直接的に導入され、典型的には、上記拡張器内に軸方向へ形成された通路または孔を使用して上記ガイド部材の外部を受ける。更に、分離レール、トラック、ガイドワイヤ等が上記ガイド部材へ取り付けられてよく、上記拡張器が上記分離要素上へ導入される。The specific construction of the guide member and dilator will depend on the nature of the body organ being accessed.It is variable. The guide member and/or dilator may be substantially rigid or substantially rigid.It is generally flexible and depends on the tortuosity of the path of entry into the body cavity. Approached from a generally straight pathFor relatively easily accessible organs, the guide member is typically rigid.Yes, with integrated sharp end or for introduction of cannula using trocarIt can be introduced by an internal stylet in a similar manner. Areas requiring meandering access routesFor organs that are difficult to access, the guide member is typically a flexible guide wire.Develop flexibility. In either case, the anchor means on the guide member isThe guide member is normally contractible or bendable, and when the anchor means is contracted, the guide member iscan be inserted or removed, and after the distal end of the guide member reaches inside the body cavity.Only the above anchor means one means to extend. Applying a force onto the distal end of the guide memberan internal rigid wire to provide tension along the length of the guide member;Suitable stiffening means, such as wheels, may be selectively introduced into the guide member. The above dilator is, typically introduced directly onto the guide member, typically with a shaft within the dilator.A channel or hole formed in the direction is used to receive the exterior of the guide member. Furthermore, separation rails, tracks, guide wires, etc. are attached to the guide member.Then, the dilator is introduced onto the separation element.
第１の特定態様において、上記ガイド部材は中心孔を有する管状体である。上記アンカ一手段は偏向自在要素であり、上記管状ガイド部材の遠位端部近傍に固定され、かつ上記軸孔内で収縮形態または伸張形態を採ることかでき、上記軸孔を半径方向へ横切って延びかつ上記円筒状ガイド部材の反対壁内に形成された開口部がら突出する。通常、偏向自在要素はばね付きであって拘束されていないときは半径方向へ突出する形態を採る。後者の場合、スタイレットか摺動自在に設置されて上記偏向自在要素を収縮形態へ移動（および維持）させる。従って、上記管状ガイド部材とスタイレットは最初に体腔へ導入され、典型的には、該スタイレットは鋭利先端部を有していて進入を促進する。上記アンカ一部材か一旦適所に設置されると、上記スタイレットは除去されて上記偏向自在要素が伸張形態を採る。そこで、上記ガイド部材は外方または後方へ引っ張られて上記偏向自在要素が体腔の内面へ付勢されると共に上記ガイド部材上の張力は維持される。かかる張力を維持しなから、軸孔を存する拡張器を上記ガイド部材上へ導入できる。In a first particular embodiment, the guide member is a tubular body having a central hole. the aboveThe anchor means is a deflectable element and is secured near the distal end of the tubular guide member.and can take a contracted form or an expanded form within the axial hole, and the axial hole isan opening extending radially across and formed in an opposite wall of the cylindrical guide member;protrude from the body. Deflectable elements are typically spring-loaded and when unconstrainedtakes the form of protruding in the radial direction. In the latter case, stylet or slidable installationto move (and maintain) the deflectable element into a contracted configuration. Therefore, the aboveThe tubular guide member and stylet are first introduced into the body cavity, typicallyThe let has a sharp tip to facilitate entry. Place the above anchor part in place once., the stylet is removed and the deflectable element assumes the extended configuration.take. Therefore, the guide member is pulled outward or backward and the deflectable member is pulled outward or backward.The tension on the guide member is maintained while the element is forced toward the inner surface of the body cavity. KakaWhile maintaining tension, a dilator with an axial hole can be introduced onto the guide member.
上記軸孔は上記ガイド部材を摺動自在に受けて、上記拡張器か上記ガイド部材の遠位端部へ達するときに上記偏向自在要素と整合して収容する。上記拡張器は除去できかつ所望径の穿孔か形成されるまで同様にして継続的により大きい拡張器と置換できる。上記処置の全工程中上記ガイド部材上の張力が維持されるので上記偏向自在要素により加拓えられる圧 濠力か身体器官または体腔の近位壁の周囲筋膜からの剥離を禁止する。１．−かかる張力は更に上記ガイド部材と組織連続層への初期穿刺路との整合を維持して上記拡張器に加わる圧縮力に起因する上記ガイド部材の座屈に抵抗する。このようにして、拡大された穿孔が上記ガイド部材の初期設置により形成された所望路に沿って形成される。The shaft hole slidably receives the guide member, and the dilator or the guide member is connected to the shaft hole.Upon reaching the distal end, it is received in alignment with the deflectable element. The above dilators are excluded.successively larger dilators in the same manner until the perforation is removed and the desired diameter is formed.can be replaced with The tension on the guide member is maintained during the entire procedure.The pressure exerted by the deflectable element may be applied around the proximal wall of a body organ or cavity.Dissection from the perifascia is prohibited. 1. - Such tension is further applied to the guide member and the tissueDue to the compressive force exerted on the dilator, maintaining alignment with the initial puncture path into theresists buckling of the guide member; In this way, the enlarged perforation guides the aboveIt is formed along the desired path formed by the initial installation of the member.
他の態様において、細長いガイド部材は可撓性カテーテルまたは可撓性ガイドワイヤ等の可撓性中空部材であってよい。上記可撓性細長部材は穿孔、中空身体器官へ自然に連設された内部管または通路、またはそれらの組み合わせにより所望中空身体器官へ導入されてよい。上記可撓性細長部材を適所に設置した後に、中実コアワイヤ等の剛性内部材を上記可撓性細長部材の中心孔から導入して上記剛性部材の遠位端部を上記可撓性細長部材の遠位端部と係合させる。In other embodiments, the elongated guide member is a flexible catheter or guidewall.It may be a flexible hollow member such as an ear. The flexible elongated member is a perforated, hollow body organ.desired internal pipes or passageways, or a combination thereof, with natural access to theMay be introduced into hollow body organs. After installing the flexible elongated member in place,A rigid internal material such as a real core wire is introduced through the center hole of the flexible elongated member to increase the rigidity.A distal end of the elastic member is engaged with a distal end of the flexible elongated member.
そこで、上記剛性部材は上記可撓性細長部材の遠位端部へ張力を付与するために使用され、そのようにして、上記可撓性細長部材および上記剛性内部材を含む最終組立体を強固または硬直にする。、上記強固にされた細長部材組立体はより大きい拡張器および／またはワーキングカテーテルを従来法によりその外部上へ導入するために使用できる。このようにして、ガイド通路は、特に、蛇行路を通過する場合に、初期に導入されたものよりも強固になる組立体により画定される。The rigid member is then configured to apply tension to the distal end of the flexible elongate member.and, as such, comprises the flexible elongate member and the rigid inner member.Make the final assembly strong or rigid. , the stiffened elongated member assembly is largerIntroducing the threshold dilator and/or working catheter onto its exterior using conventional methods.It can be used to enter. In this way, the guide path can, in particular, pass through a tortuous path.defined by an assembly that is stronger than the one originally introduced.
上記強固にされた組立体はある種の解剖に付加的利益をもたらす。蛇行路の場合、上記強固部材はその通路を直線状にする傾向があり、しばしばその曲率を減少させてカテーテル／拡張器の導入を容易にする。上記強固組立体は、また、制限された通路内の適所にそれ自体を埋蔵または係止し、上記部材をカテーテル／拡張器がその上へ導入されるときに適所に定着させる傾向がある。The stiffened assembly provides additional benefits for certain dissections. In the case of a meandering road, the rigid member described above tends to straighten its passage and often reduces its curvature.to facilitate introduction of the catheter/dilator. The above rigid assembly also has limitationsembed or lock itself in place within the passageway where the member is catheterized/expanded.It tends to settle in place when the tensioner is introduced onto it.
本発明による方法例として、上記可撓性ガイド部材組立体を十二指腸、共通胆管、および包嚢管から胆嚢へ導入する。As an example of a method according to the invention, the flexible guide member assembly described above may be inserted into the duodenum, common bile duct,, and is introduced into the gallbladder through the cystic duct.
図面の簡単な説明図１は本発明の原理によって構成された特定拡張型組立体を示す。Brief description of the drawingFIG. 1 illustrates a particular expandable assembly constructed in accordance with the principles of the present invention.
図２は図１の拡張器組立体のガイド部材とスタイレットの立面図であり、ガイド部材は断面で示されている。FIG. 2 is an elevational view of the guide member and stylet of the dilator assembly of FIG.The parts are shown in cross section.
図３は図１の拡張器組立体の拡張器要素の前端面図である。3 is a front end view of the dilator element of the dilator assembly of FIG. 1; FIG.
図４はガイド部材を適所に有する拡張器要素の断面図である。FIG. 4 is a cross-sectional view of the dilator element with the guide member in place.
図５は図４の５−５線に沿った断面図である。FIG. 5 is a sectional view taken along line 5-5 in FIG. 4.
図６は図１〜５の拡張器に使用できるガイド部材の他の態様である。FIG. 6 is another embodiment of a guide member that can be used with the dilator of FIGS. 1-5.
図７は図１〜５の拡張器に使用できる本発明のガイド部材の第２態様である。FIG. 7 shows a second embodiment of the guide member of the present invention that can be used with the dilators of FIGS. 1-5.
図８および図９は図１〜５の拡張器に使用できる本発明のガイド部材の第３態様を示す。Figures 8 and 9 show a third embodiment of the guide member of the present invention that can be used with the dilators of Figures 1 to 5.shows.
図１Ｏ〜１２は図１〜５の拡張器組立体を利用して本発明の原理によって実施する方法を示す。FIGS. 1O-12 illustrate how the dilator assembly of FIGS. 1-5 may be implemented in accordance with the principles of the present invention.We will show you how to
図１３は蛇行路から中空身体器官へ拡張器および／またはワーキングカテーテルを導入するのに有用な本発明の原理により構成された装置を示す。Figure 13 shows dilators and/or working catheters from tortuous passages to hollow body organs.1 illustrates an apparatus constructed in accordance with the principles of the present invention useful for implementing.
図１４は図１３の装置の近位端部の詳細断面図である。FIG. 14 is a detailed cross-sectional view of the proximal end of the device of FIG. 13.
図１５は図１３の装置の遠位端部の詳細断面図である。FIG. 15 is a detailed cross-sectional view of the distal end of the device of FIG. 13.
図１６〜１８はワーキングカテーテルを逆方法により胆嚢へ導入する場合の図１３〜１５の装置の使用方法を示す。Figures 16 to 18 are Figure 1 when the working catheter is introduced into the gallbladder by the reverse method.3 to 15 show how to use the device.
好適態様の説明本発明は多様目的から種々の中空身体器官および体腔へ経皮穿孔を形成かつ拡張するのに役立つ。初期穿孔および続く拡張の寸法は臨界的でなく広範囲に変化してよい。初期穿孔は患者の外傷を最小限にするために針または他の小さい道具を用いて形成された、通常、非常に小さい穿刺である。目的器官に依り、穿刺道具は約３フレンチ（Ｆ）（ここで１フレンチは０．３３ｍｍである）から約８Ｆの範囲の大きさであってよ（、通常、約４Ｆから６Ｆの範囲である。この初期穿孔は約１０Ｆから約３０Ｆの最終径、典型的には約１２Ｆから約２８Ｆ。Description of preferred embodimentsThe present invention enables the creation and expansion of percutaneous perforations into various hollow body organs and cavities for a variety of purposes.Helpful. The dimensions of initial perforation and subsequent expansion are not critical and vary widely.It's fine. The initial puncture should be done with a needle or other small tool to minimize trauma to the patient.Usually very small punctures made using Depending on the target organ, puncturing toolranges from about 3 French (F) (where 1 French is 0.33 mm) to about 8 F.This initial drillinghas a final diameter of about 10F to about 30F, typically about 12F to about 28F.
そして通常は約１４Ｆから２４Ｆへ拡張される。本発明は特により大きい径の穿孔の形成に有用である。この穿通目的はドレナージ、器官内薬剤投与、栄養補給、潅流、吸引等にあるか、通常、介入処置を目的とするような比較的大きいワーキングカテーテルの導入にある。It is usually expanded from about 14F to 24F. The invention is particularly useful for larger diameter holes.Useful for forming pores. The purpose of this penetration is drainage, intra-organ drug administration, and nutritional support., perfusion, suction, etc., or typically for relatively large workpieces intended for interventional procedures.Introducing the King catheter.
かかる介入処置は腹腔鏡検査、管のバルーン拡張、ステントの設置等を含む。穿通は特に胃腸の栄養補給管の設置および同時係属出願第０７／４０７．８２９号、同第０７１５２９．０７７号、同第０７１５５１．９７１号等の上記参考発明に記載のごとく熱切除カテーテルの導入に適する。Such interventional procedures include laparoscopy, balloon dilation of vessels, placement of stents, and the like. perforatedParticularly relevant to the installation of gastrointestinal feeding tubes and co-pending application no. 07/407.829., No. 071529.077, No. 071551.971, etc.Suitable for the introduction of thermal ablation catheters as described in .
経皮穿孔は事実上の如何なる中空身体器官または体腔、特に胆嚢、胃、膀胱、子宮、腎等へ形成される。本発明の方法および装置は、また、血管およびその他の小さい中空身体構造および管へ穿孔を形成するのに役立つ。後者の穿孔はアクセスを可能にするために可撓性ガイド部材を必要とし、他方、前者の穿孔は往々にして比較的硬質のガイド部材により形成される。Percutaneous puncture can be performed on virtually any hollow body organ or body cavity, especially the gallbladder, stomach, bladder, andFormed into the cervix, kidneys, etc. The methods and devices of the invention also apply to blood vessels and otherUseful for forming perforations into small hollow body structures and canals. The latter perforation isrequires a flexible guide member to allow forIt is formed by a relatively hard guide member.
本発明による拡張器組立体は体腔へ１以上の拡張部材を導入するための通路を形成する細長いガイド部材を含む。このガイド部材は近位端部および遠位端部を有し、かつ特定用途に依り概ね可撓性または硬質構造を有する。硬質ガイド部材は、目標器官へ実質的直線線路に沿って接近するときに概ね使用され、可撓性ガイド部材は、通常、蛇行路を通る場合に採用される。硬質ガイド部材は金属、代表例としてステンレススチール、硬質プラスチック等から形成される。他方、可撓性ガイド部材は代表的にはステンレススチールまたはＮ１ｔｉｎｏｌワイヤから形成されても、またシリコンゴム、ポリウレタン、塩化ポリビニール、ナイロン等の有機ポリマーから押し出し成形されてよい。後者の場合、意図される用途に適した可撓性を得るために補強されてよい。Dilator assemblies according to the present invention define a passageway for introducing one or more dilator members into a body cavity.and an elongated guide member having a shape. The guide member has a proximal end and a distal end.and generally have a flexible or rigid structure depending on the specific application. Hard guide member, generally used when approaching a target organ along a substantially straight line, with flexible guidesA dome member is usually used when passing through a meandering road. The rigid guide member is typically metal.For example, it is made of stainless steel, hard plastic, etc. On the other hand, flexibleThe sexual guide member is typically made of stainless steel or N1tinol wire.Also formed of silicone rubber, polyurethane, polyvinyl chloride, nylonIt may be extruded from organic polymers such as. In the latter case, for the intended useIt may be reinforced to obtain suitable flexibility.
上記ガイド部材の長さは可変である。胃等の皮膚表面に近い体腔にアクセスするのに適した約１０から２０ｃｍの範囲で長さの比較的短いガイド部材であっても、腎等の体腔に適する約２０から４０ｃｍの範囲の長さのものであってもよい。The length of the guide member is variable. Access body cavities close to the skin surface, such as the stomachEven if the guide member is relatively short in length in the range of about 10 to 20 cm, it is suitable forThe length may range from about 20 to 40 cm, making it suitable for body cavities such as the kidneys.
ガイドワイヤの性質により更に長いガイド部材であっても血管その他の遠隔管へ拡張部材を挿入するために使用できる。かかる場合、上記ガイドワイヤの長さは約４０から１５０ｃｍの範囲または更に長くてもよい。Due to the nature of the guide wire, even longer guide members can be used to reach blood vessels and other distant vessels.Can be used to insert expansion members. In such a case, the length of the guide wire above should beIt may range from about 40 to 150 cm or even longer.
一般的に、あまり遠隔でない身体器官へ直線路に沿ってアクセスするために使用されるより短いガイド部材は概ね硬質構造であり、他方、蛇行路に沿ってより遠隔の身体器官および管へアクセスするためのより長いガイド部材は可撓性構造である。しかし、この相関関係は必須ではなく、短く直線的なアクセス路に沿って中空身体器官へアクセスするために可撓性ガイド部材を利用することか望まれる場合もある。Generally used to access less distant body organs along a straight pathThe shorter guide members used are generally of rigid construction, while the shorter guide membersLonger guide members are of flexible construction for accessing septal body organs and canals.be. However, this correlation is not required; along short, straight access roads,It is desirable to utilize a flexible guide member to access hollow body organs.In some cases.
上記ガイド部材は中実断面を有していてよい。即ち、中実ロッドまたはワイヤの形態であってよいが、通常は中心孔または軸孔を存する管状体である。上記軸孔はスタイレットの上記ガイド部材への導入を可能にしく更に詳細に後述する）、または可撓性ガイド部材の場合には従来法により可動ガイドワイヤ上への導入を可能にする。The guide member may have a solid cross section. i.e. solid rod or wireAlthough it may have any shape, it is usually a tubular body with a central or axial hole. Above shaft holeallows the introduction of the stylet into the guide member (described in more detail below),Alternatively, in the case of flexible guide members, conventional methods can be used to introduce them onto a movable guidewire.enable.
当然ながら、大抵の場合には、上記ガイド部材はそれ自体ガイドワイヤの性質に依存し、例えば既知方法によるネスト状コイルから形成されてよい。Of course, in most cases the guide member itself is in the nature of a guidewire.may be formed, for example, from nested coils according to known methods.
は上記ガイド部材の遠位端部近傍に設置されるアンカ一手段から成り、この遠位端部は中空身体器官内または他の遠隔位置に固定され、患者の外に保持されている上記ガイド部材の近位端部上で外方へ引っ張ることにより張力が付与される。comprises an anchor means located near the distal end of said guide member, said distalThe end is fixed within a hollow body organ or other remote location and held outside the patient.Tension is applied by pulling outwardly on the proximal end of the guide member.
但し、他の緊張手段が使用されてよい。例えば、所望張力を与えるために分離した細長い剛性部材を上記ガイド部材内へまたはその外側へ同軸に挿入してよい。However, other tensioning means may be used. For example, separate to give the desired tension.An elongated rigid member may be inserted coaxially into or outside the guide member.
更に、上記緊張手段は、所望の細長い張力を与えるために上記ガイド部材を一体的に加圧するための手段を含む。上記ガイド部材を緊張させるための他の試案が当分野の熟練者に自明であろう。Further, the tensioning means may be integral with the guide member to provide the desired elongated tension.including means for applying pressure. Another proposal for tensioning the above guide member isIt will be obvious to those skilled in the art.
上記ガイド部材を中空身体器官内へ定着するための手段は上記ガイド部材の遠位端部近傍またはその遠位端部へ設けられる。このアンカ一手段は、典型的には、収縮自在または屈曲自在であって、上記ガイド部材を上記アンカ一手段に邪魔されることなく導入または放出てきるものである。上記アンカ一手段は上記ガイド部材力１ら外方へ選択的に伸張または拡張されて中空身体器官内またはその近傍領域内の構造と保合できるようにする。それにより、外方へ引っ張ることにより上記ガイド部材上へ張力が加えられる。上記ガイド部材が体腔へ穿通ずる場合には、通常、上記アンカーはその穿孔に近位の体腔の内面領域と係合する。このようにして上記アンカ一手段上に定常張力を維持することにより、体腔壁は適所に維持され、続く拡張処置の間、その近位または周囲筋膜からの剥離を免れる。The means for securing the guide member within the hollow body organ is distal to the guide member.Provided near the end or at its distal end. One means of this anchor is typicallyThe guide member is freely retractable or bendable, and the guide member is not obstructed by the anchor means.It can be introduced or released without being released. One way to anchor the above is the guide above.The member force 1 is selectively stretched or expanded outwardly within or near the hollow body organ.Make it possible to integrate with the structure within the area. Thereby, by pulling outwardTension is applied onto the guide member. When the above guide member penetrates into a body cavityTypically, the anchor engages the interior surface area of the body cavity proximal to its bore. This wayBy maintaining steady tension on the anchor means, the body cavity wall is held in place.maintained and spared from detachment from its proximal or surrounding fascia during subsequent expansion procedures.
上記アンカ一手段の構造は臨界的でない。例えば、上記アンカ一手段は、身体器官の制限領域内または管に隣接して設置されるときに膨張してそこへ留置される膨張自在バルーンであってよい。更（こ、上記アンカー手段は可撓性ガイド部材の一部であってもよく、この一部は剛性であってよく、管または中空器官の蛇行領域内に留置されて上記ガイド部材の放出を防止するものであってよい。上記アンカーは機械的に作動する偏向自在要素であるのが至便であり、例えば、ケーブルまたは他の作動手段を上記ガイド部材内に採用する。The structure of the anchor means is not critical. For example, one of the above anchor means is a body organ.When placed within a restricted area or adjacent to a pipe, it is expanded and retained there.It may be an inflatable balloon. Furthermore, the above anchor means is a flexible guide member.This part may be rigid and the tortuosity of the tube or hollow organThe guide member may be placed within the region to prevent release of the guide member. Above aConveniently the anchor is a mechanically actuated deflectable element, e.g.or other actuating means are employed within the guide member.
更に、上記偏向自在要素は拘束構造から解放される、または外部動力であるヒータにより選択的に作動する形状記憶合金から形成されてよい。Additionally, the deflectable element may be released from the restraining structure or may be exposed to an externally powered heat source.may be formed from a shape memory alloy that is selectively actuated by a motor.
実施態様において、上記アンカ一手段は管状または円筒状ガイド部材の内壁上に設置されるばね付き偏向自在フィンガである。拘束を受けない場合には、上記フィンガは反対壁内の開口部へ横方向（こ延びて身体器官の内面と係合する。偏向自在要素または他のアンカ一手段を提供するための他の機械的、電子機械的、または他の種々の系か当分野の熟練者に明らかであろう。In an embodiment, the anchor means is arranged on the inner wall of the tubular or cylindrical guide member.A spring-loaded deflectable finger is installed. If you are not subject to any restrictions, please use the above form.The finger extends laterally into an opening in the opposite wall to engage the inner surface of the body organ.Other mechanical, electromechanical, oror a variety of other systems will be apparent to those skilled in the art.
本発明の装置は、中空身体器官へ経皮拡張するときに、上記ガイド部材により形成される路に追従する手段を含む１以上の拡張部材を含む。好ましい態様として、上記系は構造的に概ね類似の複数の拡張部材を含むが、これらの拡張部材は、上記ガイド部材上へ連続的により大きい拡張器を導入することにより経皮穿孔の寸法が拡大するように連続的に拡大する断面を有する。通常、路追従手段は上記拡張器の１側上に形成された軸チャンネルであって上記ガイド部材上を通過すると同時に上記偏向自在要素のための間隙を有する。The device of the present invention is shaped by the guide member during percutaneous expansion into a hollow body organ.and one or more expansion members including means for following the path made. As a preferred embodiment, the system includes a plurality of expansion members that are generally similar in structure;percutaneous perforation by introducing successively larger dilators onto the guide member.It has a cross-section that expands continuously so that it increases in size. Usually, the road following means isan axial channel formed on one side of the dilator and passing over the guide member;At the same time, it has a gap for the deflectable element.
上記拡張部材が軸チャンネルを含む場合には、上記ガイド部材の近位端部近傍にキ一手段を設けるのが望ましく、それにより軸チャンネル上の長孔か上記ガイド部材の遠位端部上の上記アンカ一手段と半径方向へ整列する。このようにして、上記長孔は、上記拡張器が上記アンカ一手段に達するときに、例えば、半径方向に延びる偏向自在要素等のアンカ一手段を必ず通すことができる。通常、上記拡張器は穿通を容易にするためにその遠位端部で先細りになっており、かつ上記拡張器は、上記拡張器およびガイド部材が拡大穿孔から除去された後に適所に維持できる分離可動ガイドワイヤの導入等の他の目的から１またはそれ以上の付加孔を選択的に含んでよい。上記拡張部材は円形断面を有するのが典型的であるが、他の断面形状が採用できる。If the expansion member includes an axial channel, the expansion member may include an axial channel near the proximal end of the guide member.It is preferable to provide a key means, so that the elongated hole on the axial channel or the above-mentioned guideradially aligned with said anchor means on the distal end of the member. In this way,The elongated hole may e.g.An anchor means, such as a deflectable element, extending from the bottom to the top can necessarily be passed through. Normally, the above expansionThe tensioner is tapered at its distal end to facilitate penetration andThe dilator remains in place after the dilator and guide member are removed from the enlarged bore.One or more additional holes can be separated for other purposes such as introduction of a movable guidewire.may be selectively included. Typically, the expansion member has a circular cross section;Other cross-sectional shapes can be used.
上記拡張部材の寸法は比較的小さい、即ち、約１０Ｆから比較的大きい、即ち約３０Ｆの範囲で変更するのか典型的である。継続的に大きくなる拡張器間の寸法の増分は約３Ｆから６Ｆ、更に普通には約４Ｆから５Ｆのオーダで増加する。このようにして、約３０Ｆのオーダの比較的大きい穿孔を形成するために約５個の拡張器を使用する必要かある。当然ながら、この拡張器の寸法の許容増分増加は拡張される組織の弾性、周囲筋膜と身体器官との結合の脆性、および利用される上記アンカ一手段の支持面領域に大きく依存する。組織弾性が低くければ、筋膜結合は脆くなり、また上記支持面領域か小さくなれば、拡張器の直径の増分増加は小さくなる。The dimensions of said expansion member range from relatively small, i.e., about 10F to relatively large, i.e., about 10F.It is typical to change it within the range of 30F. Dimensions between dilators that increase continuouslyThe increments are on the order of about 3F to 6F, more commonly about 4F to 5F. childabout 5 holes to form a relatively large hole on the order of about 30F.Do I need to use a dilator? Naturally, the allowable incremental increase in the dimensions of this dilator isThe elasticity of the tissues being expanded, the fragility of the connections between the surrounding fascia and body organs, and theMuch depends on the support surface area of the anchoring means. If tissue elasticity is low, the fasciaThe bond becomes brittle, and the smaller the bearing surface area, the smaller the incremental increase in dilator diameter.becomes smaller.
図１から５を参照すると、本発明の原理に従って構成された拡張器組立体１０は鋭利遠位端部１２および近位端部にハンドル１４を存するスタイレット１１から成る。スタイレット１１は近位端部１８と遠位端部２０を有する管状ガイド部材１６の軸孔１５に受けられる。偏向自在要素２２は軸孔１５内に設けられ、鎖孔の軸と概ね整合する長さを有する（スタイレット１１が位置決めされるときに）。開口部２４が管状ガイド部材１６の壁内の偏向自在要素２２と概ね反対の位置に形成されている。偏向自在要素２２はばねであり、拘束されない形状において（即ち、スタイレット１１が軸孔１５から除去されたとき）、図２の点線および図５の実線により示された半径方向へ延びた位置になる。しかし、所定位置のスタイレット１１と共に、偏向自在要素２２は図２の実線で示されたように収縮位置で下方向へ偏向する。このようにして、偏向自在要素２２は、ガイド部材１６とスタイレット１１との組立体が体腔へ導入またはそこから除去されるときに収縮形状になる。これについては更に詳細に後述する。偏向自在要素２２はスタイレット１１を単に除去することにより伸張形態へ解放され、偏向自在要素２２は図５のごとく拘束されない形態になる。Referring to FIGS. 1-5, a dilator assembly 10 constructed in accordance with the principles of the present invention includes:From a stylet 11 having a sharp distal end 12 and a handle 14 at the proximal end.Become. Stylet 11 is a tubular guide member having a proximal end 18 and a distal end 20.It is received in the shaft hole 15 of 16. The deflectable element 22 is provided in the shaft hole 15 and is located in the chain hole.(when stylet 11 is positioned) having a length that is generally aligned with the axis of. The opening 24 is located generally opposite the deflectable element 22 in the wall of the tubular guide member 16.is formed. Deflectable element 22 is a spring and in an unconstrained configuration(i.e., when the stylet 11 is removed from the shaft hole 15), the dotted line in FIG.The radially extending position shown by the solid line in FIG. 5 is reached. However, the spot in placeTogether with the tielet 11, the deflectable element 22 is in the retracted position as shown in solid line in FIG.deflects downward at the position. In this way, the deflectable element 22and stylet 11 when the assembly is introduced into or removed from a body cavity.It becomes a contracted shape. This will be described in more detail later. The deflectable element 22 is a style.By simply removing let 11, the deflectable element 22 is released into the extended configuration.It becomes an unrestricted form as shown in FIG.
拡張器組立体１０の第３構成要素は先細遠位端部３２と軸長孔３６を有する概ね円筒状の間である拡張器３０である。軸孔３４はガイド部材１６の外部上を通過できる大きさであり、長孔３６は上記ガイド部材上に係止できる大きさである。The third component of dilator assembly 10 has a generally tapered distal end 32 and an axial slot 36.The dilator 30 is a cylindrical spacer. The shaft hole 34 passes over the outside of the guide member 16The elongated hole 36 is large enough to be locked onto the guide member.
長孔３６の開口部は拡張器３０が後述のごとく体腔へ導入さるときに偏向自在要素２２を通って前進できるような間隙を形成している。かかる間隙は図４で最良に観察できる。ガイド部材１６の遠位端部上に形成されたタブ３７のようなキ一手段（図１および２）は拡張器３０が上記ガイド部材の下で前進するときに長孔３６と偏向自在要素２２とを的確に整合させる。内孔４０は拡張器３０内に選択的に設けられて、拡張処置か完了した後にガイドワイヤを経皮穿孔へ導入させるために使用できる。上記ガイドワイヤが一旦上記内孔を通過すると、拡張器３０、ガイド部材１６およびスタイレット１１を含む拡張器の全組立体はガイドワイヤを適所に残して除去される。The opening of the elongated hole 36 is designed to be deflectable when the dilator 30 is introduced into a body cavity as described below.A gap is formed through which the element 22 can be advanced. Such a gap is the best in Figure 4.can be observed. A key such as tab 37 formed on the distal end of guide member 16Means (FIGS. 1 and 2) allows the dilator 30 to be inserted into the elongated hole as the dilator 30 is advanced under said guide member.36 and the deflectable element 22. Internal bore 40 is selected within dilator 30the guidewire is introduced into the percutaneous hole after the dilation procedure is completed.can be used for Once the guidewire has passed through the lumen, dilator 30, the entire dilator assembly including guide member 16 and stylet 11 is attached to the guide wire.removed leaving the layer in place.
１つの拡張器３０のみが図示されているが、連続的に拡大する径を育する複数の拡張器が、後述のごとく、本発明の方法を実施するために設けられてよい。本発明の特定利点は、結果として、穿孔される組織上への圧縮力となる上記ガイド部材上の張力維持により誘導される。かかる圧縮力は、拡張器が導入されるときに種々の組織層を保持して組織層を分裂または分離させることなく可能な限りのより大きな径の拡張器の使用を可能にする。このようにして、所定寸法の穿孔に必要とされる拡張器の総数を減少させる。Although only one dilator 30 is shown, a plurality of dilators 30 are shown that grow successively increasing diameters.A dilator may be provided to carry out the method of the invention, as described below. Main departureA particular advantage of this is that the guide section results in a compressive force on the tissue being pierced.Induced by maintaining tension on the material. Such compressive forces are applied when the dilator is introduced.Preserve the various tissue layers to the extent possible without disrupting or separating the tissue layers.This allows the use of larger diameter dilators. In this way, the requiredReduces the total number of dilators required.
図６から９を参照すると、いくつかの異なるアンカ一手段か図示されている。図６において、ガイド部材５０は鋭利遠位先端５２を有する中空針から成る。ガイド部材５０の側の開口部５４は、破線で示されたように、アンカーワイヤ５８のばね先端部５６の外方への突出を可能にする。第１に、ばね先端部５６は完全にダブルバックしく右手破線位置に図示されたように）、該ばね先端部は、該アンカーワイヤが近位へ引っ張られる（図６の左へ）ときに該開口部を通って外へ移動する。このようにして、ガイド部材５０は予め形成された切開部から導入され、図１から５に示されたと同様に拡張器はばね先端部５６が解放された後にその上へ導入される。Referring to FIGS. 6-9, several different anchoring arrangements are illustrated. figureAt 6, the guide member 50 consists of a hollow needle with a sharp distal tip 52. guyThe opening 54 on the side of the anchor wire 58 is shown in broken lines.This allows the spring tip 56 to protrude outward. First, the spring tip 56 is completely(as shown in the right-hand dashed line position), the spring tipWhen the car wire is pulled proximally (to the left in Figure 6) it moves out through the opening.move. In this manner, guide member 50 is introduced through the preformed incision., similar to that shown in FIGS. 1-5, the dilator is opened after the spring tip 56 is released.introduced above.
図６のガイド部材は図１および２のスタイレット１１と同様の除去可能なスタイレットを使用かつ導入できるように変形されることができる。かかる変形（図示せず）において、鋭利先端部５２はその軸から除去され、そしてその遠位先端部は開放される。そこで、ガイド部材５０は鋭利先端部を有するスタイレット共に導入される。上記ガイド部材の設置後に、該スタイレットは除去され、かつアンカーワイヤ５８はそのガイドワイヤの軸孔へ挿入される。選択的に、上記アンカーワイヤは、ガイド部材へ挿入されるときに折り畳んだ形態で該ワイヤを維持する荷重管に収容されてよい。The guide member of FIG. 6 is a removable stylet similar to the stylet 11 of FIGS. 1 and 2.can be modified to allow the use and introduction of Such deformations (as shown)(without), the sharp tip 52 is removed from its shaft and its distal tipwill be released. Therefore, the guide member 50 is used together with a stylet having a sharp tip.be introduced. After installation of the guide member, the stylet is removed and unlocked.The car wire 58 is inserted into the axial hole of the guide wire. Optionally, the above anchor- The wire maintains the wire in a folded configuration when inserted into the guide member.may be housed in a load tube.
図７には第２態様のガイド部材が図示され、ここでは開放遠位端部６２を存するガイド部材６Ｑは拘束されていないときにＬ形先端部を有するアンカーワイヤ６４を受ける。このガイド部材６０は分離ガイドワイヤ、除去可能ハブ、または従来形態の針上で中空体腔へ導入されることができる。反対に、ガイドワイヤ６０は続いて除去される鋭利スタイレットと共に導入されてよい。選択的に該スタイレット、ガイドワイヤまたは針を除去した後に、アンカーワイヤ６４は、前方ばね先端部６６が開放遠位端部６２から解放されて、破線で示された偏向形態となるように挿入される。アンカーワイヤ５８（図６）および６４（図７）は従来のばねステンレススチールまたはＮ１ｔｉｎｏ１等の高記憶合金から形成されてよい。該ばねを適宜形態で拘束する荷重管が負荷を簡素化するために使用できる。A second embodiment of the guide member is illustrated in FIG. 7, here having an open distal end 62.The anchor wire 6 has an L-shaped tip when the guide member 6Q is not restrained.Receive 4. This guide member 60 may be a separate guidewire, a removable hub, or aIt can be introduced into a hollow body cavity on a conventional needle. On the contrary, the guide wire 60may be introduced with a sharpened stylet that is subsequently removed. Selectively select the styleAfter removing the let, guide wire or needle, the anchor wire 64 isThe spring tip 66 is released from the open distal end 62 into the deflected configuration shown in dashed lines.It will be inserted as shown below. Anchor wires 58 (FIG. 6) and 64 (FIG. 7) are conventionalSprings should be made from stainless steel or a high memory alloy such as N1tino1.stomach. A load tube that constrains the spring in a suitable configuration can be used to simplify loading.
図８および９を参照すると、ガイド部材７０の第３態様が示されている。ガイド部材７０は硬質外カニユーレ７２とセグメント付き内ロッド７４を含む。ロッド７４は鋭利遠位先端部７８を有する遠位セグメント７６、中間セグメント８０、および近位セグメント８２を含む。セグメント７６、８０および８２は概ね中空であって、遠位セグメント内に形成されたスェージ域により遠位セグメント７６内に固定された弾性部材８４により一緒に保持されている。該ガイド部材か中空体腔の所望領域内でその遠位端部によって適所に設置された後に、外カニユーレ７２は内ロッドの遠位セグメント７６および中間セグメント８０か露出するように近位方向へ放出されてよい。ロッド７４の遠位構造を屈曲させるために、ロッド部材７４の遠位セグメント７６の先端部へ固定される縫合糸８８へ張力が加えられてよい。このようにして、遠位セグメント７６と中間セグメント８０を図９のごとき形状に屈曲させる。そこで、拡張部材（図示せず）を上記アンカ一手段として作用する内ロッドの屈曲セグメント７６と８０と共に外カニユーレ７２上へ前進させる。Referring to FIGS. 8 and 9, a third embodiment of guide member 70 is shown. guideMember 70 includes a rigid outer cannula 72 and a segmented inner rod 74. rod74 is a distal segment 76 having a sharp distal tip 78; an intermediate segment 80;and proximal segment 82. Segments 76, 80 and 82 are generally hollowthe distal segment 76 by a swage region formed within the distal segment.They are held together by resilient members 84 secured within. The guide member is hollowAfter being placed in place by its distal end within the desired area of the body cavity, the external cannula72 to expose the distal segment 76 and intermediate segment 80 of the inner rod.may be released in a proximal direction. To bend the distal structure of rod 74,Tension is applied to the suture 88 which is secured to the distal end of the distal segment 76 of the lead member 74.It's okay to be rejected. In this manner, the distal segment 76 and the intermediate segment 80 are separated from each other in FIG.Bent it into a shape like this. Therefore, an expansion member (not shown) is attached to the above-mentioned anchor.on outer cannula 72 with flexural segments 76 and 80 of the inner rod acting asadvance to.
図１Ｏから１２を参照すると、腹Ａから胃Ｓへ経皮穿孔を形成するために図１から５の拡張器組立体の使用方法か図示されている。最初に、ガイド部材１６とスタイレット１１を含む組立体ｌＯを、アクセスを可能にする該スタイレットの鋭利突出端部１２を用いて腹壁Ａから導入する。選択的に、初期穿孔を針または他の穿孔装置を用いて形成してよい。ガイド部材１６を導入後、スタイレット１１を除去して図１１に示されたように偏向自在要素２２をガイド部材１６から伸張゛した形態にする。そこで、ガイド部材１６を矢印９０の方向で外方へ引っ張って偏向自在要素２２か該穿孔領域内の胃の内面Ｉｓと係合するようにする。Referring to FIGS. 1O to 12, in order to form a percutaneous perforation from abdomen A to stomach S, FIG.The method of using the dilator assembly of et al. 5 is illustrated. First, the guide member 16 and theThe assembly lO containing the stylet 11 is assembled with the sharpness of the stylet to allow access.It is introduced through the abdominal wall A using the protruding end 12. Optionally, make the initial perforation with a needle or otherThe holes may be formed using a drilling device. After introducing the guide member 16, the stylet 11to extend the deflectable element 22 from the guide member 16 as shown in FIG.Make it look like this. Then, pull the guide member 16 outward in the direction of arrow 90.so that the deflectable element 22 engages the inner surface Is of the stomach within the perforation area.
図７に示されたように、張力下でガイド部材１６を設置することにより胃Ｓの内壁は上にある筋膜に対して引っ張られる。次に、図８に示されたように、ガイド部材１６上の張力を維持しながら第１拡張器３０をガイド部材１６上に導入する。最終的に使用される拡張器３０の数および寸法は経皮穿孔の所望寸法に依存する。所望寸法にした後に、ガイド部材１６を前進させて胃Ｓの内面Ｉｓから要素２２を離脱させることにより張力を解放する。第２孔４０（図２から５）へより大きな拡張器へ組み合わされてよいガイドワイヤか選択的に導入されてよい。As shown in FIG. 7, by placing the guide member 16 under tension, the inside of the stomach S isThe wall is pulled against the overlying fascia. Next, as shown in Figure 8, the guideIntroducing first dilator 30 onto guide member 16 while maintaining tension on member 16. The number and size of dilators 30 ultimately used will depend on the desired size of the percutaneous perforation.Ru. After obtaining the desired dimensions, the guide member 16 is advanced to remove the element from the inner surface Is of the stomach S.22 releases the tension. From the second hole 40 (Figures 2 to 5)A guidewire that may be combined into a large dilator may be selectively introduced.
偏向自在要素２２を収縮させるためにスタイレット１１をガイドワイヤ１６へ再導入する。そこで、拡張器３０、ガイド部材１６、およびスタイレット１１を、大きな鞘またはワーキングカテーテルの挿入に適した比較的大きい管内へガイドワイヤを残したまま、該穿孔から除去する。Replace the stylet 11 onto the guidewire 16 to retract the deflectable element 22.Introduce. Therefore, the dilator 30, the guide member 16, and the stylet 11 areGuide into relatively large vessels suitable for insertion of large sheaths or working cathetersRemove the wire from the borehole, leaving it in place.
図１３から１５を参照すると、細長いガイド部材組立体１００は可撓性管状性組立体１０２および剛性内部材１０４を含む。可撓性管状外部材１０２はねじ付き受容器１０６の近位端部およびフランジ要素１０８内の遠位端部で終端する。詳細に後述するように、剛性内部材１０４にストッパ部材を提供するために金属リング１１０が設けられるのが便利である。Referring to FIGS. 13-15, elongate guide member assembly 100 includes a flexible tubular assembly.It includes a solid body 102 and a rigid internal member 104. Flexible tubular outer member 102 is threadedIt terminates at the proximal end of receiver 106 and at the distal end within flange element 108 . DetailsAs described in detail below, a metal ribbon is provided to provide a stopper member for the rigid inner member 104.Conveniently, a ring 110 is provided.
上記可撓性管状外部材の性質は臨界的でなく、中空ポリマー管、金属ガイドワイヤ等の形態であってよい。しかし、管状部材１０２は後述の胆嚢に逆アクセスするための特定基準として説明されるような比較的蛇行した通路から中空身体器官へ導入できるだけの柔軟性が必要である。The properties of the flexible tubular outer material described above are not critical, and include hollow polymeric tubes, metal guide wires, etc.It may be in the form of However, the tubular member 102 is used for reverse access to the gallbladder as described below.hollow body organs from relatively tortuous passages described as specific criteria forIt is necessary to be flexible enough to introduce it to
剛性内部材１０４は雄ねじ要素１１２の近位端部で終端し、かつチュービングを容易にするためにノブが取り付けられている。図１５に最良に示されたように、丸い頭部を有するピン１１６が剛性内部材１０４ダ１２０がストッパリング１１０と係合するまで可撓性管状部材１０２の孔１２２へ挿入されてよい。そこで、ハウジング１０６内へねじ部材１１２を締めつけることにより、張力が該可撓性ガイド部材へ加わって、全長に沿って該部材は硬直になる。かかる硬直ガイド組立体１００はワーキングカテーテル、拡張器等を中空身体器官へ導入するために優れた通路を提供する。この硬直ガイド部材は座屈、不整合、その他のワーキングカテーテル、拡張器等が導入されるときに生じる変形に抵抗する。この硬直部材は、更に、蛇行路を直状にし、アクセスを改良し、特に、その硬直端部か制限された通路内に留置されるときには該硬直遠位端部を定着させる。A rigid internal member 104 terminates at the proximal end of the externally threaded element 112 and connects the tubing.A knob is attached for ease. As best shown in Figure 15,The pin 116 with a round head is connected to the rigid internal member 104 and the stopper ring 110 may be inserted into the bore 122 of the flexible tubular member 102 until it engages the flexible tubular member 102. Therefore,By tightening threaded member 112 into housing 106, tension is applied to the flexibleIn addition to the guide member, it becomes rigid along its entire length. rigidity guide setThe solid body 100 is used for introducing working catheters, dilators, etc. into hollow body organs.Provides excellent passage. This rigid guide member is free from buckling, misalignment, and other working problems.resists deformation that occurs when catheters, dilators, etc. are introduced. This stiff partThe material also straightens meandering paths and improves access, especially at its rigid ends or restrictions.The rigid distal end is anchored when placed within the passageway.
図１６から１８は十二指腸Ｄ、共通胆管ＣＢＤ、および包嚢管（ｃｙｓｔｉｃｄｕｃｔ） ＣＤから胆嚢ＧＢヘワーキングカテーテルを導入する過程を説明する。第１に、可撓性管状外部材１０２を上記通路から導入する。ワーキングカテーテルＷＣに対比して小さい径を有する可撓性管状外部材＋０２の高い可撓性か遭遇する蛇行路への通過を容易にする（図１６）。Figures 16 to 18 show the duodenum D, common bile duct CBD, and cystic duct.uct) Explain the process of introducing the gallbladder GB working catheter from the CD. First, a flexible tubular outer member 102 is introduced through the passageway. working catheterThe high flexibility of the flexible tubular outer material +02 with a smaller diameter compared to the Tel WC(Figure 16).
可撓性管状外部材１０２の導入後に、剛性内部材１０４を孔１２２へ挿入し、かつ得られた組立体１を硬直化するために張力を付与する。図１７から明らかなように、最終組立体１００を直状にするため、特に蛇行包嚢管へ十分な張力を加える。After introducing the flexible outer tubular member 102, the rigid inner member 104 is inserted into the hole 122 andTension is applied to stiffen the resulting assembly 1. It is clear from Figure 17.Apply sufficient tension, especially to the tortuous capsular canal, to straighten the final assembly 100.Ru.
最後に、図１８を参照すると、ワーキングカテーテルＷＣ（または可撓性孔付き拡張器）か従来法により細長いガイド部材組立体１００の外部上へ導入されている。剛性内部材１０４による張力はガイド部材組立体１００の整合を維持するのに役立つと同時にワーキングカテーテルＷＣか遠位方向へ前進するときの該ガイド部材の放出、座屈、屈曲、その他の変形を防止しなからワーキングカテーテルの導入を可能にする。ワーキングカテーテルＷＣ（または同等の拡張器）はガイド部材組立体１００上への該カテーテルの導入を容易にするためにその長手の一部または全長に沿って長孔（図示せず）を含むのが便利である。更に、ガイド部材組立体１ｏｏが導入されがっ硬直化される間、ガイド部材組立体＋００の近位長上でワーキングカテーテルｗｃ上記発明は理解を容易にする目的で詳細に説明したが、所定の改変か添付の請求の範囲内で可能であることは自明であろう。Finally, referring to FIG. 18, working catheter WC (or flexible boredilator) is introduced onto the exterior of elongate guide member assembly 100 in a conventional manner.Ru. The tension provided by the rigid internal member 104 maintains the alignment of the guide member assembly 100.This guide is useful when advancing the working catheter WC distally.Prevents extrusion, buckling, bending, or other deformation of the working catheter.enable the introduction of The working catheter WC (or equivalent dilator) isThe length of the catheter is fixed to facilitate introduction of the catheter onto the catheter assembly 100.It may be convenient to include slots (not shown) along the entire length. Furthermore, the guide partProximal to guide member assembly +00 while member assembly 1oo is introduced and stiffened.The above invention has been described in detail for ease of understanding.However, it will be obvious that certain modifications may be made within the scope of the appended claims.
ＦＩＧ ６ＦＩＧ Ｂ。FIG 6FIG B.
ＦＩＧ １２゜ＦＩＧ、１３゜ＦＩＧ、１５Ｆｌに ｌ？ＦＩＧ Ｂ。FIG 12゜FIG, 13°FIG. 15Fl to l?FIG B.
特表千６−５０２７９１ （９）国際調査報告一一一−１ｍ 帥−ｍ−Ｎ４． ＰＣＴ ／ＴＪｓ９１ ／Ｃ８１ａ ３５Special table 16-502791 (9)international search report111-1m Marshal-m-N4. PCT /TJs91 /C81a 35
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US61612290A | 1990-11-20 | 1990-11-20 | |
| US616,122 | 1990-11-20 |
| Publication Number | Publication Date |
|---|---|
| JPH06502791Atrue JPH06502791A (en) | 1994-03-31 |
| JP3269556B2 JP3269556B2 (en) | 2002-03-25 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP50227592AExpired - LifetimeJP3269556B2 (en) | 1990-11-20 | 1991-11-12 | Apparatus for forming percutaneous perforations in body cavities |
| Country | Link |
|---|---|
| US (2) | US5275611A (en) |
| EP (1) | EP0558642B1 (en) |
| JP (1) | JP3269556B2 (en) |
| AU (1) | AU652979B2 (en) |
| CA (1) | CA2096651A1 (en) |
| DE (1) | DE69123982T2 (en) |
| WO (1) | WO1992008513A1 (en) |
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